Better living through chemistry? A randomized, double‐blind controlled study evaluating the efficacy of plaque control and gingival health impacts of a novel stannous fluoride‐containing gel

Abstract

Background: Gingivitis is a nonspecific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis.Enhanced oral hygiene practices are necessary to reverse gingivitis and a dentifrice that could provide significant clinical reductions in plaque accumulation and gingival inflammation would be desirable to treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a novel stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra-acetic acid (EDTA) as an antitartar agent to reduce Plaque Index (PI) and Gingival Index over a 3-month study period. Methods: This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using either a novel dental gel containing 0.454% stannous fluoride and 2.6% EDTA or a dentifrice with 0.24% sodium fluoride. Sixty subjects participated over a 3-month period. Co-primary endpoints were improvements in PI and Modified Gingival Index (mGI) from baseline values. No professional cleaning was performed during the study period. Results: All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using the novel dental gel showed statistically significantly greater reductions in PI (ΔPI) [(−1.43 ± 0.34; −0.49 ± 0.13) (p < 0.00001)], mGI (ΔmGI) [(−1.11 ± 0.22; −0.16 ± 0.12) (p < 0.00001)], and modified sulcular bleeding index (ΔmSBI) [(−1.15 ± 0.18; −0.20 ± 0.07) (p < 0.00001)]. Conclusions:The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice.

A randomized double‐blind clinical trial evaluating comparative plaque and gingival health associated with commercially available stannous fluoride‐containing dentifrices as compared to a sodium fluoride control dentifrice

“…Previous studies have reported on the impact of the D1 dentifrice formulated without fluoride in patients with gingivitis and periodontitis. [20][21][22][23][24][25][26]31 These studies have demonstrated enhanced plaque reduction and improved gingival health in patients with gingivitis. 20,31 Additionally, when the D1 formulation without fluoride was utilized in Stage I/II periodontitis patients [32][33][34] investigators demonstrated increased reductions in periodontal probing depths, plaque, and gingival inflammation and bleeding when compared to control dentifrice.…”

“…Previous studies have reported on the impact of the D1 dentifrice formulated without fluoride in patients with gingivitis and periodontitis 20–26,31 . These studies have demonstrated enhanced plaque reduction and improved gingival health in patients with gingivitis 20,31 .…”

“…19 While all tartar control toothpastes contain chelators (e.g., sodium hexametaphosphate, sodium pyrophosphate aka tetrasodium pyrophosphate, sodium tripolyphosphate aka pentasodium triphosphate, malic acid copolymer, citric acid, EDTA aka edathamil, and others); previous studies have demonstrated the efficacy of a new dental gel with EDTA, in reducing oral plaque deposits, gingival inflammation, and probing depths with minimal patient-reported side effects or impact upon tooth surface microarchitecture and microhardness. [20][21][22][23][24][25][26] While only one of these reports evaluates a formulation that includes stannous fluoride, 26 the comparative efficacy of a similar dentifrice formulation without stannous fluoride in plaque and gingival inflammatory reduction is consistent across studies. [20][21][22][23][24][25][26] A critique of previous investigations included a lack of comparison between multiple commercially-available dentifrices, including a direct comparison with other stannous fluoride formulations.…”

“…[20][21][22][23][24][25][26] While only one of these reports evaluates a formulation that includes stannous fluoride, 26 the comparative efficacy of a similar dentifrice formulation without stannous fluoride in plaque and gingival inflammatory reduction is consistent across studies. [20][21][22][23][24][25][26] A critique of previous investigations included a lack of comparison between multiple commercially-available dentifrices, including a direct comparison with other stannous fluoride formulations. [20][21][22][23][24][25][26] This study sought to investigate the effects of a new dental gel toothpaste containing 0.454% stannous fluoride (Livionex, Los Gatos, CA) on clinical plaque deposits and gingival inflammation in patients without providerdelivered care over a 3-month period.…”

“…[20][21][22][23][24][25][26] A critique of previous investigations included a lack of comparison between multiple commercially-available dentifrices, including a direct comparison with other stannous fluoride formulations. [20][21][22][23][24][25][26] This study sought to investigate the effects of a new dental gel toothpaste containing 0.454% stannous fluoride (Livionex, Los Gatos, CA) on clinical plaque deposits and gingival inflammation in patients without providerdelivered care over a 3-month period. The new dentifrice was compared to four other commercially available dentifrices.…”